]>
IRCT2017022213776N4 IRCT 2017-03-07 Sobhan Medicine Trade Development Company Bioequivalence study of ledipasvir/sofosbuvir 90/400 mg tablets under fasting conditions A study to compare the relative bioavailability of SMTD and Gilead formulations of ledipasvir/sofosbuvir 90/400 mg tablets in 24 healthy adult male volunteers under fasting conditions 2017-04-01 anticipated 24 Complete https://irct.ir/trial/13558 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Health service research. Bioequivalence Healthy volunteers. Intervention 1: Single dose ofone ledipasvir/sofosbuvir 90/400 mg tablets manufactured by Sobhan Medicine Trade Development Company. Intervention 2: Single dose of one Harvoni (ledipasvir/sofosbuvir) 90/400 mg tablets manufactured by Gilead.
public Dr. Hossein Amini
Golshahr Bolv., Golshahr 14, Aftabgardan Bulding, No. 6
Gorgan Iran (Islamic Republic of) +98 21 3252 5972 haminhplc@yahoo.com Gorgan Bioanalysis Center scientific Dr. Hossein Amini
University Main Campus
Gorgan Iran (Islamic Republic of) +98 17 3252 5972 haminhplc@yahoo.com Golestan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: 1. Males, 18-50 years of age (inclusive). 2. The subject is able and willing to provide written informed consent. 3. The subject is available for the entire study period and is willing to adhere to protocol requirements as evidenced by written informed consent. 4. The subject has stable residence and telephone. 5. Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening. Exclusion criteria: 1. History of allergy or sensitivity to ledipasvir/sofosbuvir, or history of any drug hypersensitivity or intolerance which, in the opinion of the investigator, would compromise the safety of the subject or the study. 2. Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction. 3. Presence of gastrointestinal disease or history of malabsorption within the last year. 4. Presence of a medical condition requiring regular treatment with prescription drugs. 5. Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing. 6. Receipt of any drug as part of a research study within 30 days prior to dosing. 7. Donation or significant loss of whole blood (480 ml or more) within 30 days prior to dosing. 18 years 50 years Male Y41.5 Antiviral drugs Treatment - Drugs Treatment - Drugs Single dose ofone ledipasvir/sofosbuvir 90/400 mg tablets manufactured by Sobhan Medicine Trade Development Company Single dose of one Harvoni (ledipasvir/sofosbuvir) 90/400 mg tablets manufactured by Gilead Maximum plasma concentration (Cmax). Timepoint: After intervention. Method of measurement: Blood sampling. Area-under the curve (AUC) for plasma concentrations. Timepoint: After intervention. Method of measurement: Blood sampling. Time to reach Cmax (Tmax). Timepoint: After intervention. Method of measurement: Blood sampling. Sobhan Medicine Trade Development Company Approved 2017-01-15 Golestan University of Medical Sciences Km 2 Sari Road Gorgan Gorgan Iran (Islamic Republic of)